Hearing Aid Devices: Professional and Patient Labeling and Conditions for Sale

ICR 200203-0910-005

OMB: 0910-0171

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0171 200203-0910-005
Historical Active 199911-0910-004
HHS/FDA
Hearing Aid Devices: Professional and Patient Labeling and Conditions for Sale
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 03/29/2002
Retrieve Notice of Action (NOA) 03/29/2002
  Inventory as of this Action Requested Previously Approved
04/30/2002 04/30/2002 01/31/2003
1,600,000 0 1,600,000
986,369 0 986,369
0 0 0

FDA is requiring that certain information be included in the labeling to provide hearing health professionals and patients with adequate directions for the sale and effective use of a hearing aid. In addition, FDA requires that the hearing aid dispenser obtain a medical evaluation demonstrating that the hearing aid purchaser had their hearing loss evaluated 6 months prior to the sale of the aid or, if an informed adult elects to waive the medical evaluation requirement, a waiver statement. Respondents include manufacturers and hearing aid dispensers.

None
None


No

1
IC Title Form No. Form Name
Hearing Aid Devices: Professional and Patient Labeling and Conditions for Sale

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 1,600,000 1,600,000 0 0 0 0
Annual Time Burden (Hours) 986,369 986,369 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
03/29/2002


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